Overview

Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
Summary
Periodontitis is a form of gum disease that affects many people in the world. Its traditional protocol of treatment includes oral hygiene instruction and dental scaling to remove debris, dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option also usually cheaper. In this last one, all above described procedures are performed within 24 hours. However, up to now comparative effectiveness between these both types of treatment is not well understood. For, example it is not clear if patients treated in the shorter-time experienced more pain. Therefore, the present study used several parameters to clarify whether beneficial differences between these therapeutic protocols exist or not. In addition, aspects that could help clinicians' and patient's decisions such as experience of pain and anxiety related to dental treatment were also investigated. After receiving verbal and written explanations and signed the informed consent form 150 individuals (n=15/group) having the most common type of periodontitis in adults were randomly allocated to be treated in 4 weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were performed alone or in conjunction with antimicrobial agents: a mouth rinse containing chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral debris and malodor; quantification of bacteria in plaque samples collected with paper points from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect information about oral condition, daily activities, pain and anxiety related to dental treatment.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Taubate
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Treatments:
Azithromycin
Chlorhexidine
Chlorhexidine gluconate
Criteria
Inclusion Criteria:

- mild to moderate chronic periodontitis;

- at least 20 natural teeth;

- good general health

Exclusion Criteria:

- systemic diseases or other conditions that could influence the periodontal status;

- events of high blood pressure or diagnosed hypertension;

- alcohol abuse;

- orthodontic devices;

- extended prosthetic fixed devices, removable partial dentures or overhanging
restorations;

- pregnancy or breast-feeding;

- history of sensitivity or suspected allergies following the use of oral hygiene
products and/or the test antibiotic;

- the need for antibiotic prophylaxis;

- antibiotics and/or anti-inflammatory drug use in the three months prior to the
beginning of the study;

- regular use of chemotherapeutic antiplaque/antigingivitis products;

- any furcation lesions;

- periodontal treatment performed within six months prior to study initiation;

- unwillingness to return for follow-up.